Clinical trials: Bipolar I Depression
Bipolar Depression
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
- Trial name
- NCT01986101
- Testing
- SM-13496
- Where
- 8 sites in Japan, Lithuania and 6 more
- Volunteers
- 525 people
- Sponsor
- Sumitomo Pharma Co., Ltd.
Bipolar Depression, Bipolar I Disorder
iTBS in Bipolar I Depression
A multisite, open label pilot study to investigate the efficacy and safety of a novel accelerated intermittent theta-burst stimulation (iTBS) protocol while assessing for changes in neuroimaging biomarkers associated with…
- Trial name
- NCT05375214
- Testing
- Magnus Transcranial Magnetic Neuromodulation System (MNS) with SAINT®(Stanford Accelerated Intelligent Neuromodulation Therapy)
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
Schizophrenia, Schizoaffective Disorder
Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
The overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic naive children and adolescents in order to inform…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychosis NOS
- Trial name
- NCT01731119
- Testing
- Latuda©
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of North Carolina, Chapel Hill
Bipolar Depression
Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B.
- Trial name
- NCT02600494
- Testing
- ITI-007 (Lumateperone)
- Where
- 55 sites in United States
- Volunteers
- 554 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Depressive Disorder, Depressive Disorder, Major
Synaptic Imaging and Network Activity in Treatment Resistant Depression
The main aim of this research is to explore the effects that ketamine has on the functional connectivity of the brain in participants with treatment resistant depression (TRD).
- Conditions
- Depressive Disorder, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Bipolar Disorder
- Trial name
- SIGNATURE (NCT05870501)
- Testing
- Ketamine, Midazolam
- Where
- United Kingdom
- Volunteers
- 56 people
- Sponsor
- King's College London
Bipolar I Disorder, Current Episode Depressed
Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression
The purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression.
- Trial name
- NCT01655030
- Testing
- creatine monohydrate
- Where
- Brazil
- Volunteers
- 44 people
- Sponsor
- University of Sao Paulo
Bipolar Disorder, Bipolar Depression
Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression
This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases.
- Conditions
- Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- NCT03603561
- Testing
- cTBS
- Where
- 2 sites in Belgium
- Volunteers
- 40 people
- Sponsor
- Universiteit Antwerpen
Schizophrenia, Bipolar I Disorder
Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine
The purpose of this study is to assess the PK, Safety, Tolerability (all cohorts) and Efficacy (cohort 3), of once-a-month long-acting SC injection of dose escalating Cariprazine Depot in subjects eligible for treatment with oral…
- Conditions
- Schizophrenia, Bipolar I Disorder, Major Depressive Disorder
- Trial name
- NCT07185815
- Testing
- Cariprazine Depot, Cariprazine Depot MTD, Oral Cariprazine 3 mg/day
- Where
- 6 sites in India, Israel
- Volunteers
- 24 people
- Sponsor
- Mapi Pharma Ltd.
Seasonal Affective Disorder, Mood Disorders
Clinical Trials of Three Non-Drug Treatments for Winter Depression (SAD)
We are offering non-pharmacologic therapy for alleviation of symptoms associated with depressed mood that recurs annually in fall or winter.
- Conditions
- Seasonal Affective Disorder, Mood Disorders, Depression
- Trial name
- NCT00006517
- Testing
- bright light box, dawn simulator, high-output negative ion generator
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- New York State Psychiatric Institute
Bipolar Depression, Bipolar I Disorder
SYNCED - SYNChronized Eating in Bipolar Depression Study
Bipolar disorders (BD) are a group of complex disorders that impact mood, behaviour and cognition and are known to cause significant suffering and impairment.
- Conditions
- Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder
- Trial name
- NCT06560957
- Testing
- Time restricted eating, Eating ad libitum with nutritional counselling
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University of Ottawa
Bipolar I Depression
Lurasidone Pediatric Bipolar Study
A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression
- Trial name
- Illuminate (NCT02046369)
- Testing
- Lurasidone
- Where
- 66 sites in United States, Bulgaria and 9 more
- Volunteers
- 350 people
- Sponsor
- Sumitomo Pharma America, Inc.
Depression
Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.
- Trial name
- NCT01121536
- Testing
- Armodafinil
- Where
- 158 sites in United States, Argentina and 15 more
- Volunteers
- 867 people
- Sponsor
- Cephalon
Major Depressive Episode, Bipolar Depression
NeoSync TMS Treatment for Bipolar I Depression
This study is designed to evaluate the safety and preliminary efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Bipolar Disorder type I in a…
- Conditions
- Major Depressive Episode, Bipolar Depression, Bipolar Disorder, Mood Disorders
- Trial name
- NESTTBID (NCT02839798)
- Testing
- NEST (NeoSync EEG Synchronized TMS)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Butler Hospital
Depression
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major…
- Trial name
- NCT01305408
- Testing
- Armodafinil
- Where
- 130 sites in United States, Argentina and 12 more
- Volunteers
- 399 people
- Sponsor
- Cephalon
Bipolar I Disorder, Depression
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
This is a sequential multiple assignment randomized trial for adults (ages > 18) with a bipolar disorder type 1 and type 2 diagnosis currently experiencing a depressive episode.
- Trial name
- SMART-BD (NCT06433635)
- Testing
- Cariprazine, Aripiprazole/Escitalopram combination, Quetiapine
- Where
- 18 sites in United States, Canada
- Volunteers
- 2,726 people
- Sponsor
- Massachusetts General Hospital
Schizophrenia, Major Depressive Disorder
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar I Disorder
- Trial name
- NCT02722967
- Testing
- Aripiprazole + IEM (Ingestible Event Marker)
- Where
- 4 sites in United States
- Volunteers
- 49 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder, Type 1
Evaluation of Theta-burst Stimulation Efficacy, Safety and Tolerability in Major Depressive Episodes of Bipolar I Disorder
INTRODUCTION: Pharmacological treatment of major depressive episodes in bipolar disorder (BD) is characterized by suboptimal efficacy rates, poor tolerability and adherence, delayed onset of action, and iatrogenic mood swings.
- Trial name
- NCT05501626
- Testing
- Active Theta Burst Stimulation (TBS)
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- University of Sao Paulo
Depressive Episodes, Bipolar I Depression
A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression).
- Trial name
- NCT05227209
- Testing
- SEP-4199 CR
- Where
- 69 sites in United States, Bulgaria and 1 more
- Volunteers
- 64 people
- Sponsor
- Sumitomo Pharma America, Inc.
Depression in Patients With Bipolar Disorder
Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.
- Trial name
- NCT00622245
- Testing
- Lu AA34893, Quetiapine fumarate
- Where
- 50 sites in Australia, Austria and 16 more
- Volunteers
- 166 people
- Sponsor
- H. Lundbeck A/S
Bipolar Depression
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective…
- Trial name
- PREVAIL3 (NCT01284517)
- Testing
- Lurasidone
- Where
- 75 sites in United States, Canada and 8 more
- Volunteers
- 356 people
- Sponsor
- Sumitomo Pharma America, Inc.